ES3034252T3 - System and method for quality assured analytical testing - Google Patents

Abstract

A system for quality-assured testing in the field of extracorporeal analytical testing is described, comprising: an analytical instrument (40) for performing analytical tests, which has an input section for user identification and is adapted to execute a test routine. An examination module is programmed to perform an examination during which it: asks the user questions related to the analytical instrument (40) and/or a diagnostic test to be performed with it, receives the user's answers to the questions and evaluates them, determines whether the user has passed the examination, and if passed, the examination module transmits a user certificate to the analytical instrument. The analytical instrument (40) is programmed to check whether a user is certified according to the entered user identification. The analytical instrument (40) is programmed to grant access to the test routine only if the user is certified. (Automatic translation with Google Translate, no legal value)

Description

DESCRIPTION

System and procedure for quality-assured analytical tests

Field of the invention

The present invention relates to the field of analytical testing for diagnostic purposes. Diagnostic testing is valuable in providing physicians with clinical data to support their diagnoses and medical actions. One field of diagnostic testing is carried out with large analytical instruments in specialized laboratories. These instruments are operated by highly specialized operators who are very well trained for this purpose. Another field of diagnostic testing primarily addressed by the present invention is called bedside testing or bedside testing. This type of diagnostic testing is performed by nurses or medical personnel primarily trained in patient care and not highly focused on the use of diagnostic instruments. Therefore, quality assurance for this type of testing is much more difficult to achieve, especially given the large number of people involved. In the field of bedside testing, tests are typically performed on the patient by nurses, medical staff, or physicians, who are collectively referred to as "users" in this document.

According to the prior art, there is little assurance of the quality of analytical testing, which mostly relies on self-training by users or by an administrator/supervisor who trains users in person so that the quality of the diagnostic tests they perform is sufficient and reliable. US patent 6,386,882 B1 discloses a training and certification software for implantable medical devices. US patent application 2008/0184330 A1 relates to providing access to advanced medical diagnostic imaging applications only for trained users. US patent application

2002/0001794 A1 discloses a procedure for training users in the understanding and use of medical devices.

Certain testing instruments, such as the Accu-Check Inform from Roche Diagnostics, allow you to control who can perform tests. For this purpose, a user list is stored on the instrument, and only these users are allowed to log in and perform tests. User registration is performed by a supervisor based on their personal decision.

The present invention allows for much stricter and more reliable control of instrument use, so that only well-trained users with proven knowledge are permitted to perform tests with the analytical instrument. For this purpose, examinations are established for users wishing to be certified to perform tests. Checking the answers of the tested users in response to questions that relate to the particular analytical instrument and/or an analytical test to be performed ensures that all users of an analytical instrument have sufficient knowledge of the instrument and related test procedures. Erroneous or unreliable test data can thus be largely avoided. Conducting the examination with a computerized, preferably web-based, examination resource ensures that all important topics are covered that a human trainer in case-by-case user training might forget. Furthermore, the examination conditions can be guaranteed to be the same for all tested users, thereby ruling out the trainer's personal preferences. As mentioned above, a large number of people are involved in bedside testing and so individual training of these people by a supervisor/trainer would require great efforts which can be reduced by the present invention.

The present invention relates to a system for quality-assured analytical testing, the system comprising an analytical instrument having an input section for determining a relevant user and further having a testing section for performing a test routine. The system of the invention comprises an examination module programmed to perform an examination on a potential user, during which it asks the user questions relating to the analytical instrument and/or a diagnostic test to be performed therewith, and receives the user's answers to the questions and evaluates the answers. The examination module further determines whether the user has passed the examination and, if so, transmits a user certificate to the analytical instrument. The analytical instrument is programmed to control access to a test routine by the user and only provides access to it if a user certificate is available for the relevant user.

The invention further relates to a method for quality assured analytical testing comprising the steps of

- ask a user questions that relate to analytical tests to be performed or an analytical instrument to be used

- receive user input to those questions

- evaluate the inputs and determine the degree to which the inputs are correct.

If the degree of correct answers determined is higher than a threshold, the user will be certified.

Before analytical testing, the user is prompted to enter a user ID, and the instrument determines whether the user is a certified user. If the user is certified, access is provided to an analytical instrument test routine.

Analytical tests according to the present invention mean that a patient sample is reacted with reagents to perform a chemical or biochemical reaction that results in a detectable change that allows an analyte to be detected or quantified.

Typical patient samples include blood, saliva, tissue, interstitial fluid, cerebrospinal fluid, and the like. Such patient samples are often treated before performing analytical tests. Blood drawn from a patient is centrifuged, for example, to obtain serum, or treated with anticoagulants to obtain plasma. The term "patient sample" also refers to the original, treated patient samples.

According to the present invention, the patient sample is extracted from the patient prior to analytical testing, for example, using a vacuum-sealed blood sampling container, a syringe, or a finger prick and collecting the blood with a test element. This means that the analytical testing is performed extracorporeally.

Analytical tests aim to determine the presence and/or concentration of an analyte in a patient sample. "Analyte" is a general term for substances for which information on the presence and/or concentration is intended. Exemplary analytes include glucose, coagulation parameters, endogenous proteins (e.g., proteins released by the myocardium), metabolites, nucleic acids, and so on.

Reagents for analytical tests are well known in the art. Typical reagents include, for example, enzymes that react with an analyte to produce detectable products or, for example, antibodies that specifically bind to an analyte (i.e., an immunological reaction) to indicate the presence and/or concentration of the analyte.

According to the present invention, analytical tests are preferably performed with test elements containing reagents, which are discarded after the analytical tests. Such test elements are, for example, the well-known test strips for testing blood glucose or test strips for measuring coagulation parameters. However, test elements in the form of cartridges are also available, for example, for immunological tests.

An analytical instrument according to the present invention is preferably a bedside testing instrument, such as a blood glucose or coagulation meter. An analytical instrument according to the present invention may also be an analytical instrument such as that used in bedside testing or in intensive care, such as a blood gas analyzer. These analytical instruments are typically operated by medical personnel who are not primarily employed to set up and manage analytical instruments.

Analytical instruments determine the presence and/or concentration of analytes by measuring detectable changes due to the reaction of analytes with reagents. Suitable detection methods include optical (e.g., absorption, remission, fluorescence) or electrochemical (e.g., amperometric, conductometric, coulometric, etc.).

Analytical instruments according to the present invention have an integrated or colocated input section for receiving user input such as user IDs, passwords, and information related to analytical tests. The input section may also receive information regarding the patients being tested (e.g., patient ID, age, sex).

The input section typically comprises a display and input keys or a keyboard. If a touch screen is used, the additional input keys may be obsolete. The input section at least allows for the input of information that allows the identification of the user in question. In this regard, the input section may also be a barcode reader, a fingerprint reader, an ID card reader, or similar for reading an identification medium in the user's possession.

The instrument further comprises a microprocessor programmed to perform a test routine to carry out an analytical test. The instrument checks whether the user in question is a certified user and, if so, allows them to carry out the test routine. This can be done by selecting the test routine on the instrument, for example, by pressing a key on the instrument (e.g., a region on a touch screen). The instrument then carries out the analysis, for example, by treating an electrochemical test strip with a voltage profile and reading a current profile, or by illuminating an optical strip and recording the reflected light. Additional user interactions may be required, such as entering calibration data, inserting/changing test elements, or entering comments.

Other types of analysis, such as those in the field of blood gas testing, are well known and are therefore not described in more detail here.

A system according to the present invention further comprises an examination module that is programmed to perform an examination. The examination module may be a programmed computer and is interactive in that it asks questions to a user and receives answers. The examination module may also reside on a programmed analytical instrument, on the Internet, or may even be distributed in certain physical locations such as a server of an instrument management system and a client computer. The questions are typically configured or selected by an administrator and replace those questions that would otherwise be asked of a user in person to verify whether the user can operate the analytical instrument or perform a diagnostic test without systematic errors.

In accordance with the present invention, it is also possible to configure standard examinations by specialists and provide the EMS administrator with complete examinations or modules from which to choose. Such specialists may be, for example, employees of the analytical instrument manufacturer who are familiar with the details of the instruments and also the legal/regulatory requirements for clinical testing. Therefore, the present invention provides an option for hospitals and laboratories to employ administrators who focus on administration, but who do not need to be experts in analytical testing or know analytical instruments in great detail. The questions posed by the examination module may relate to the pre-analytical testing phase, which involves instrument handling or patient preparation (e.g., cleaning a puncture site on the patient's skin where a blood sample is to be drawn). The questions may also relate to the testing procedure itself, for example, how a test strip or a module of a blood gas analyzer is fed with a blood sample and how the instrument is operated to perform the analysis. In addition, questions may address the post-analysis phase, which includes, among other things, the storage or transfer of analytical data and the unloading of analytical equipment (e.g., test strips or lancets) without contamination. Questions may also address clinical knowledge, materials (test strips, etc.), and maintenance.

The examination module receives responses from the user preferably in multiple-choice format, meaning that the user is presented with a series of predefined answers and can select one or more of these as correct. Receiving responses in an alternative or additional format may also involve text input by the user or a drag-and-drop examination, where the user must drop certain predefined terms into the respective sections of an analytical instrument displayed on a screen. User response input can also be performed by voice.

The exam module determines whether the user has passed the exam. This can be accomplished by simply comparing the user's answers with predefined correct answers and counting the number of correct versus incorrect answers. Such a simple evaluation of answers can be replaced or complemented by more sophisticated evaluations, as described in more detail in Figure 1.

The administrator may have the option to define the type of assessment and establish thresholds for when a user is considered sufficiently experienced to use the particular analytical instrument and perform the respective analytical test. Preferably, the computer is programmed with software that assists the administrator in configuring the questions and configuring the exam passing criteria. In the case of an exam configured/provided by a specialist or instrument manufacturer, it preferably already includes the passing criteria or at least a schema that assists the administrator in defining the passing criteria.

The examination module decides, based on the user's responses and predefined passing criteria, whether the user has passed the examination. If the user has passed, the examination module transmits a user certificate to the analytical instrument. This can be a direct transfer to the instrument(s) or can occur via intermediary devices, for example, a server running an instrument management system. Transmission of the certificate to the instrument is not limited to an unsolicited (push) service as described above, but can also be a requested (pull) service, where the instrument retrieves the certificate.

A user certificate is information or a physical embodiment thereof that allows the analytical instrument to determine whether the user in question has passed an examination and is therefore permitted to perform the tests. In particular, a user certificate according to the present invention is not restricted to embodiments titled "certificate" or physical embodiments having a related title. In a simple case, a user certificate according to the present invention is provided by a user's entry in a certified user list. In this case, the instrument checks whether the logged-in user is on the certified user list. If a user who is not on the certified user list logs in, they will not be granted access to the testing section of the analytical instrument. The entry in the user list may be a user ID, a representation of a user, and/or a password used by the user. Furthermore, the entry may comprise a certificate issue date or an expiration date. Based on this, the analytical instrument may check whether the certificate for the user in question is still valid at the time of login.

Preferably, the user certificate is stored on the analytical tool. However, it is also possible for the analytical tool to retrieve the information if the user is certified from a connected device, for example, a server.

Other details and embodiments of how such a certificate transfer can be achieved and what data/information is transmitted are described in more detail for the embodiment in Figure 1.

The analytical instrument has a microprocessor programmed to check whether a user certificate is available for the user in question. As mentioned above, the analytical instrument has an input section for determining the user in question. Based on this input and the user certificates stored in the instrument, it can be determined whether the user is certified to use the instrument and/or the particular analytical test they intend to perform. This check is described in more detail for the embodiment in Figure 1. However, it should be noted that checking the certificate may also involve checking which test the user actually wishes to perform and also a check of the current date. Checking the date is important if certificates are only valid for a certain period of time, which is often the case or may even be required by law. Checking the user's intended test makes it possible to check whether the user is certified to perform this particular analytical test. This means that certificates according to the present invention can be instrument-type specific as well as analytical test-specific. Consequently, the user may be certified only for specific tests, and thus the instrument would allow them to perform the respective tests while excluding them from other analytical tests.

The present invention further relates to a method for quality-assured analytical testing. During this method, the user is asked questions relating to the analytical test to be performed or an analytical instrument to be employed. As mentioned above, this formulation is initiated by a test program. The formulation typically appears on a screen of a workstation or other device that the user uses to run the test program. The user typically also inputs answers at the same workstation or device. The input provided by the user to answer the questions is evaluated to determine the degree of correctness. The details of this evaluation have already been described above or will be described in the context of Figure 1. If the degree of correct input is above a pre-established threshold, the user is certified as a certified user. When the user intends to perform an analytical test with an instrument, they must enter their user ID. Based on the user ID, it is determined whether the user is a certified user, meaning that a certificate is available for that particular user.

If the instrument has determined that the user is a certified user, it provides access to a test routine to allow the user to perform analytical tests.

Brief description of the drawings:

Figure 1: Workflow and setup for quality-assured analytical testing.

Figures 2 and 3: Alternative system configurations

Figure 4: Analytical device

Figure 5: Connectivity diagram for carrying out the invention

The figures describe the present invention by examples and are in no way intended to limit the scope of the present invention.

Figure 1 shows the main workflow underlying the present invention. Figure 1 represents four columns representing four different locations for carrying out the respective steps. The leftmost column shows the actions taken by a learning management system (LMS) administrator. In case the LMS administrator decides that training of users of a diagnostic instrument is necessary, he or she logs into an instrument management system (IMS) (30), for example, using a local workstation (10). An IMS comprises a computer that is directly or indirectly connected to the analytical instruments to be managed. Said computer is preferably a server, but other embodiments are also possible. The IMS computer is programmed with a software program that allows management of the connected analytical instruments. Said management comprises retrieving analytical data from the instruments and may also comprise downloading program data or content data to the instruments. Program data would program the instruments to operate differently, for example, a new input screen or a changed voltage profile for electrochemical test strip testing. Content data would include, for example, changed thresholds for warning messages or calibration data for calibrating the instruments.

The WMS administrator can retrieve user data from the IMS to review active users or changes to a user list and can create additional user accounts within the system. In addition, the WMS administrator can enter the IMS data of other users who will perform testing with analytical instruments in the future. The WMS administrator then installs an exam, meaning they configure an exam for users seeking certification or install an exam provided by an expert, for example, a manufacturer of the analytical instruments. Using a suitable software program running on workstation 10, the WMS administrator can configure an exam from scratch or retrieve a course already available in the instrument management system and modify it. The WMS administrator can also configure different exams (exam types) for different user groups and/or different types of exams for different instruments or even for different analytical tests. For example, there may be different courses for nurses and medical personnel who perform simple diagnostic tests and more advanced courses for local administrators who manage analytical instruments. This type of local administration may involve configuring instrument screens, activating certain test routines, changing user profiles, and performing instrument quality control.

After setting up a course, the LMS administrator can disseminate information that a new course is available. This information can be disseminated verbally, through information (e.g., a pop-up window) on a user terminal, or by transmitting the information to analytical devices for display on the screen. Additionally, a user of a diagnostic instrument may simply recognize the need for a reexamination due to the fact that they cannot access the analytical instrument or perform a test routine because they are no longer certified.

The next column in Figure 1 is titled "EMS Nurse." This column schematically shows a terminal for users of diagnostic instruments. When a user (in most cases a nurse) wishes to take an exam to obtain certification, they log in to the instrument management system, which can be done, for example, via an intranet or web-based tool using their terminal. The terminal can be, for example, a client computer. The user can then choose an exam dedicated to the instrument or analytical test they wish to take in the future. Once the user has chosen an exam, they are asked certain questions as defined by the EMS administrator and can enter their answers. Preferably, answers are given as multiple choices or multiple selections, but typed or voice-entered answers are also possible.

The answers given by the user in question are compared with the correct answers as defined by the LMS administrator or the exam author. If the rate of correct answers is above a threshold, the user will be registered as a certified user. The rate of correct answers can be determined by a simple number of correct and incorrect answers, or individual questions can be graded so that, for example, questions related to the prevention of analytical errors are more important than, say, knowing how to change a battery. It can also be provided that an incorrect answer to a very important question can result in failing the exam if making the same mistake in practice would result in analytical errors. If the user fails the exam, they can be decertified instead of certified.

Certification can be approached in several ways. In the simplest case, the system registers the user ID, and this user then becomes "known" to the system and can log in to the instrument or perform a test routine later. This would mean that the instrument only allows testing for users who enter a user ID known to the instrument. Decertifying a user in this context would mean removing them from the list of certified users.

Alternatively, the system can use an indicator connected to a user ID to indicate whether a given user is certified or non-certified. In the latter case, the instrument checks for a user accessing the instrument whether the indicator has a "certified" status. Instead of a simple indicator, it is also possible to use a data field indicating the date on which the respective user passed the exam or, alternatively, a future date until which the user will be certified. Both options allow for improved quality control because the EMS administrator can determine a period of time during which a certificate, once issued, is valid. In the former case, the EMS administrator can set a period of, for example, one year, and after this year has elapsed, the certificate for the respective user will be automatically withdrawn, or the instrument can recognize that the certificate has expired. If the EMS administrator sets a future date, for example, one year after passing the exam, the instrument compares this date with the actual date, and if the certificate expiration date is in the past, the instrument may deny access to its testing routine.

As further shown in Figure 1, a user can print their certificate for documentation. From a regulatory perspective, it is of utmost importance for hospitals to document that healthcare personnel are well-trained. This can be very well supported by the system according to the present invention.

Column 3 of Figure 1 shows a schematic representation of the screen (30) of the instrument management system (IMS) of the art. The core of such an IMS is typically a server on which the IMS program runs. In the case shown, the cobas IT 1000 software provided by Roche Diagnostics is used. The IMS server is connected to the analytical instruments in a manner that will be described later. Another connection of the IMS often exists with a so-called hospital information system (HIS), which contains data on patients, doctors, nurses, and so on. The IMS primarily contains data on the analytical tests performed, the instruments, and data to be used for test evaluation, such as calibration data. The IMS server can be accessed by the IMS administrator via his or her workstation (10). Users (in the present case, an EMS nurse as indicated in column 2) who wish to become certified log on to the IMS server using a workstation (20) that is, for example, installed in a nursing section. In accordance with the present invention, the IMS server may also perform the examination. Alternatively, the examination may be stored on a different computer or server. To carry out the present invention, the IMS has or receives information about which users are certified. The IMS then transmits this information to connected analytical instruments so that the instruments can later control access. As mentioned above, instead of simply certifying specific patients or a list of certified patients, the IMS may set or receive the expiration date or, alternatively, the validity period of a certificate.

The rightmost column in Figure 1 shows a diagnostic testing device. The analytical instrument depicted is an Accu-Chek Inform, available from Roche Diagnostics. Details of this instrument will be provided later.

The analytical instrument (40) receives information from the IMS according to the certified users. This may be an unsolicited service (push), where the IMS server, for example, sends a list of certified users to the analytical instrument, or it may be a requested service (pull), where the analytical instrument asks the IMS server for a list of such certified users. Alternatively, the analytical instrument may request from the IMS the certification status of a user in question who attempts to log in to the analytical instrument (40). For this purpose, the analytical instrument has an input section in which the user enters a user ID. If the user is a certified user and their certificate is valid, the analytical instrument allows access to their analytical routine. The user input and analytical testing procedure will be described in more detail later.

Figure 2 shows a different configuration of the present invention. It can be seen that the present invention can be practiced without the need for an instrument management system. According to the configuration of Figure 2, the EMS administrator sets up an exam on a workstation (10) and makes it available to users. A user can log in to his or her terminal (20) and access the EMS administrator workstation to take the exam. When the user passes the exam, he or she is certified and the EMS administrator workstation transmits the user certificate to the analytical instrument (40). Details of the manner in which certifications are transmitted to the analytical instrument have already been described with respect to Figure 1 and can be applied to the configuration of Figure 2 and analogously.

Figure 3 depicts an instrument-centric embodiment of the present invention. The EMS administrator creates a test at his or her workstation (10) and stores the test on the analytical instrument (40). The user can access the instrument from his or her terminal (20) and performs the test as provided by the analytical instrument. Based on the test result, the instrument allows the user access to the analytical testing section of the analytical instrument. Alternatively to using a workstation, the test can be performed directly on the analytical instrument. A number of instruments in intensive care units, for example, blood gas analyzers, have a display large enough to perform a test, but even on the smaller display of a handheld analytical meter and the limited input keys of such an instrument, simple tests are possible.

Figure 4 shows some more details of the analytical instrument (40) as used in the previous examples. Figure 4a shows the front of the instrument while Figure 4b shows the back. The instrument has a centrally located on/off button (41) and a so-called forward arrow button (42) for moving from one screen to another. A central feature of the instrument is the touch screen (43) which functions as a display and also allows multiple user inputs. The instrument shown uses disposable diagnostic test strips. The instrument has a slot (44) for receiving the disposable strips. In another central position the instrument has a menu button (45) for going to the main menu screen at any time.

Another characteristic feature of this meter that makes it especially useful for the hospital environment is the backlight button (46) that allows the backlight for the display to be switched on. On the bottom, the analytical instrument has a connector (47) for connecting it to a base unit that will be described later.

Figure 4b shows the rear part of the instrument having a slot 48 for receiving a coding chip. The coding chip makes it possible to calibrate the analytical instrument with respect to the batch of test strips actually used. At the top, the instrument has a scanner 49 which emits a laser beam for scanning bar codes. With this scanner 49, the instrument can read patient information, for example, from a patient's wristband, so that manual entry of a patient ID is not necessary. In addition, a bar code of the instrument user can be read to identify the user in question (thus, the bar code scanner can also be considered as an input section according to the present invention). It is furthermore possible for the user to scan a printed certificate certifying that he has passed the examination. This printout may comprise, for example, a bar code indicating the user, the examination passed and the expiry date of the certificate. To log in to the analytical section of the instrument, the user can simply scan the barcode on the printed test and thus log in to the analytical section of the instrument. In a preferred embodiment, the user must also enter a user ID and/or password, thereby preventing another person from simply taking a printout and using it for identification.

Figure 4b further represents a battery compartment (50) as well as a reset button (51).

Figure 4c shows an enlarged view of the instrument touch screen (43). As can be seen, the main menu allows the user to choose between performing a patient test, performing a control test, or reviewing test results. By pressing the "patient test" region of the touch screen, the user selects to perform a patient test and will only be granted access if they are a certified user. Alternatively, the analytical instrument may ask the user at this point for their user ID to check if the user in question is a certified user.

Figure 4d shows the base unit (55) which is also called a stand. The base unit (55) has a data port (56) and a power connector (57). When the analytical instrument (40) is placed on the base unit (55) as shown in Figure 4e, the instrument is connected to the data port as well as the power connector to charge the instrument.

The base unit may be connected via a cable or radio frequency transmitter to the instrument management system in the embodiment of Figure 1, to the administrator workstation in the case of the embodiment of Figure 2, or to an administrator workstation and a user terminal (20) in the case of Figure 3. As is well known in the art, this connection need not necessarily be a direct connection, but may also be established via servers and a network (e.g., a local area network, a wide area network, or the Internet).

Figures 4f and g also show input screens for the analytical instrument. As can be seen, the touch screen (43) allows the entry of numbers as well as alphanumeric characters. This input can be used to enter patient IDs, operator IDs, observations, messages, and other information.

Figure 5 shows a device connectivity diagram for embodying the present invention. The WMS administrator has a workstation (10) that is connected via a hospital network (typically a local area network) to a cobas IT 1000 server (60) (i.e., a server running cobas IT 1000 software). The cobas IT 1000 server in this embodiment represents the instrument management system according to the invention. The cobas IT 1000 server is connected to a client computer (70) for sampling data from the testing devices and transmitting the data to the cobas IT 1000 server. In addition, the testing device (40) is connected via a modem (80) to the cobas IT 1000 server. An exam that is configured by the WMS administrator is downloaded to the cobas IT 1000 server and may be performed by a user on the client computer (70) or on a terminal connected to the client computer. The examination software or parts thereof can be installed on the cobas IT 1000 server and on the client computer. In a preferred embodiment, the examination questions are transferred together to the client computer and the answers are transmitted back to the cobas IT 1000 server where they are evaluated. The examination result is then sent to the client computer to inform the user whether they have passed the examination. The cobas IT 1000 server updates the user list (i.e., a list of certified users) and transmits it via the client computer (70) or via the modem (80) to the analytical instrument(s) (40). It is advantageous that the IMS can be connected to a number of analytical instruments such that the updated list of certified users can be sent to them in parallel. This makes it possible for certified users to perform tests not only with one instrument, but in principle with all instruments to which their certification is sent. These are, for example, all the intensive care and bedside testing instruments located in the same hospital.

Claims (18)

1. A system for quality assured testing in the field of extracorporeal analytical testing, comprising the system - a plurality of analytical instruments (40) for carrying out analytical tests, each analytical instrument (40) of the plurality of analytical instruments comprising: • a test section configured to perform a test routine to carry out an analytical test in which a patient sample is reacted with a reagent, and • an input section configured to receive a user ID, - an examination module that is scheduled to carry out an examination during which: - asks the user questions relating to the analytical instruments (40) and/or a diagnostic test to be carried out with them, - receives responses from the user to questions and evaluates the answers, - determines whether the user has passed the exam, and - when it is determined that the user has passed the examination, it transmits a user certificate to the analytical instruments; wherein the analytical instruments (40) are each programmed to check whether a user is a certified user based on a user ID entered in the input section by checking whether the entered user ID corresponds to a user in a list of certified users, and wherein the analytical instruments (40) are each programmed to grant access to the test routine only if the user is a certified user. 2. The system according to claim 1, wherein the examination module is separated from the analytical instruments. 3. The system according to any preceding claim, wherein the analytical instruments (40) store the list of certified users. 4. The system according to any preceding claim, wherein a server transmits the list of certified users to the analytical instruments. 5. The system according to claim 4, wherein the server transmits the list of certified users to the analytical instruments as a service without requesting it (push). 6. The system according to claim 4, wherein the server transmits the list of certified users to the analytical instruments as a requested service (pulí) when the analytical instruments request the server for the list of certified users. 7. The system according to any one of the preceding claims, - wherein the list of certified users comprises an issue date or an expiration date of the respective user certificates; and - in which checking whether the user is a certified user includes - check the current date and - check if the user certificate has expired for the user. 8. The system according to any one of the preceding claims, wherein the analytical instruments (40) are configured to decertify a user by removing the user from the list of certified users. 9. The system according to any one of the preceding claims, wherein the system comprises an instrument management system (30) in which the examination module is configured to transmit the user certificates to the analytical instruments (40) using the instrument management system (30). 10. The system according to any one of the preceding claims, wherein the system comprises a terminal (20) that is different from the analytical instruments (40) and that the examination module is configured to: - formulate questions to the user that refer to the analytical instruments (40) and/or a diagnostic test to be carried out with them, and - receive responses from the user to the questions and evaluate the responses, by means of the terminal (20). 11. The system according to any one of the preceding claims, wherein each analytical instrument (40) is programmed to check whether a user is a certified user at a user login. 12. The system according to any one of the preceding claims, wherein the input section comprises a reading unit for reading identification means. 13. The system according to any one of the preceding claims, wherein the user certificate comprises a user identification. 14. The system according to any one of the preceding claims, wherein the input section and a sensor of each analytical instrument (40) that is adapted to perform a test routine are arranged in a common housing. 15. The system according to any one of the preceding claims, wherein each analytical instrument is a handheld meter. 16. The system according to any one of the preceding claims, wherein the analytical tests are performed with a test element containing a reagent that reacts with an analyte in a patient sample. 17. A quality assured extracorporeal analytical testing method for a system comprising a plurality of analytical instruments for carrying out analytical tests, each analytical instrument in the plurality of analytical instruments comprising: • a test section configured to perform a test routine to carry out an analytical test in which a patient sample is reacted with a reagent; and • an input section configured to receive a user ID; understanding the procedure in the stages of: - ask questions to a user relating to the analytical instruments (40) and/or a diagnostic test to be carried out with them, - receive user input to those questions, - evaluate the inputs and determine the degree to which the inputs are correct, - certify to the user whether the determined degree is higher than a pre-established threshold, - ask the user to enter a user ID, - determine whether the user is a certified user based on an entered user ID by checking whether the entered user ID corresponds to a user in a list of certified users, - provide access to a test routine to carry out an analytical test of the analytical instruments (40) if the user is a certified user. 18. The method according to claim 17, the method further comprising the steps of - performing an analytical test; and - transmit an analytical test result to an instrument management system (30).